The following data is part of a premarket notification filed by Pride Health Care, Inc. with the FDA for Sidekick Ii.
Device ID | K931231 |
510k Number | K931231 |
Device Name: | SIDEKICK II |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644 |
Contact | Thomas Kretchik |
Correspondent | Thomas Kretchik PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-10 |
Decision Date | 1994-05-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIDEKICK II 74385341 1881278 Live/Registered |
Aerus LLC 1993-05-03 |